Active not recruitingNAINTERVENTIONAL

Boiled Peanut Immunotherapy for the Treatment of Peanut Allergy

This study is exploring a new approach to treating peanut allergy in children and young people aged 7-18. Peanut allergy can be very serious and upsetting, with no cure currently available. Researchers are investigating if giving small, increasing amounts of boiled peanuts can help the body become used to peanuts, making allergic reactions less likely or less severe if peanuts are accidentally eaten. Previous research showed that boiling peanuts makes them less allergenic. This study wants to compare this 'boiled peanut immunotherapy' with an existing treatment using defatted peanut flour, to see if boiled peanuts are just as effective but perhaps cause fewer side effects. The goal is to find a safer and easier way for people with peanut allergy to live with their condition.

At a glance

Status

Active not recruiting

Phase

Sponsor

Imperial College London

Enrolment target

Start

29 Apr 2019

Estimated completion

01 May 2027

IgE Mediated Peanut Allergy Peanut Hypersensitivity

What is this study about?

Peanut allergy is a common and often serious food allergy, especially in children. Unlike many other childhood allergies, it often doesn't go away. Living with a peanut allergy can be very stressful for both the person affected and their family, as even tiny amounts of peanut can cause severe reactions. Currently, there's no cure, but treatments that help the body become less sensitive to peanuts are being explored.

One such treatment is called 'oral immunotherapy' (OIT), where tiny, increasing amounts of peanut are given over time. While this can be helpful, some current OIT methods can unfortunately cause significant side effects, sometimes even life-threatening ones. Researchers have found that boiling peanuts changes them in a way that makes them much less likely to cause a reaction. This is because boiling removes some of the strong allergy-triggering parts of the peanut.

This new study, called BOPI-2, builds on earlier research that showed boiled peanuts could help children with peanut allergy. The main goal is to find out if this boiled peanut treatment is as safe and effective as using a special peanut flour for treating peanut allergy in children and teenagers. The study will also look at whether there are fewer side effects with the boiled peanut approach and try to understand what makes some people more likely to benefit from the treatment than others. This could help doctors decide which treatment is best for each individual.

Key takeaways

This study is for children and teens with peanut allergy.
It tests if boiled peanuts are a safe and effective treatment.
The goal is to help people become less allergic to peanuts.
It compares boiled peanuts to a special peanut flour.
All reactions will be carefully monitored by medical staff.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

This study is looking for children and young people aged between 7 and 18 years who have an IgE-mediated peanut allergy. This means you must have a confirmed peanut allergy where your body's immune system overreacts specifically to peanuts. To join, you should be sensitive to a specific amount of peanut protein (less than about 6 peanuts) when tested, but also be able to tolerate a very tiny amount of a specially boiled peanut during a screening test, meaning you don't have a severe reaction to the boiled peanut right away.

There are also some reasons why you might not be able to join. For example, if you've had a very severe allergic reaction to peanuts that required intensive care, or if you have certain serious long-term health conditions (other than well-managed asthma, hay fever, or eczema). You also can't be taking certain medications like anti-IgE therapy or some types of heart medication. If you're pregnant, or if your asthma isn't well-controlled, you also wouldn't be able to participate. The study also cannot accept people who are already able to tolerate more than 6 peanuts.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 7 and 18 years old?
Do you have a confirmed peanut allergy?
Are you able to tolerate a very small amount of boiled peanut during a screening test?
Do you have well-controlled asthma, or no asthma at all?
Are you generally healthy, without other serious long-term illnesses?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be carefully monitored throughout. You would be randomly assigned to receive either the boiled peanut treatment or the peanut flour treatment. This means neither you nor the doctors will choose which one you get, similar to tossing a coin. You will start by taking very tiny amounts of peanut, which will gradually increase over time. This process typically takes several months, and you'll have regular visits to the clinic for check-ups and to increase your dose safely. During these visits, medical staff will carefully watch for any allergic reactions and help manage them if they occur. You'll also have tests to see how your body is responding to the treatment.

After the initial treatment phase, which lasts about six months, you might continue with a maintenance dose. Towards the end of the study, usually after about a year, you will have another test (called a food challenge) to see how much peanut your body can now tolerate. The study also involves follow-up to see if your improved tolerance continues even after stopping the treatment. The entire study could involve around 12 to 18 months of active treatment and follow-up.

Potential risks and benefits

Taking part in this study could potentially reduce your sensitivity to peanuts, which might mean that if you accidentally eat peanuts, your reaction could be less severe. In the long term, it might even allow you to eat peanuts without a reaction. However, as with any medical treatment for allergies, there's always a risk of having an allergic reaction during the study, including potentially severe ones, especially when the dose of peanut is increased. The study team will be experienced in managing such reactions. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Imperial College Healthcare NHS Trust (St. Mary's Hospital)
Verified postcode
London, United Kingdom

Common questions

What is 'oral immunotherapy'?

It's a treatment where you're given tiny, increasing amounts of an allergen (like peanut) to help your body get used to it and reduce allergic reactions.

Why boiled peanuts?

Boiling peanuts makes them less allergenic, meaning they're less likely to cause a reaction, so they might be a safer way to do immunotherapy.

Will I have to eat peanuts if I join?

Yes, you would be given small, carefully controlled amounts of peanut (either boiled peanut or peanut flour) under medical supervision.

What happens if I have an allergic reaction during the study?

The study team is highly trained to manage allergic reactions immediately and safely.

Can I stop the study whenever I want?

Yes, you can choose to leave the study at any time without needing to give a reason, and your medical care will not be affected.